The National Heart, Lung, and Blood Institute intends to
publish a new Funding Opportunity Announcement (FOA) that will encourage applications
for research in support of development of novel point-of-care (POC) and
implementation of existing technologies specifically for practical clinical
applications which can guide diagnostic and therapeutic efforts in the heart,
lung, blood, and sleep clinical research settings.

Among the areas of research encouraged in this initiative
are evidence of the development and validation of the POC tool/technology (new
or repurposed), including software development as necessary (Phase I), with
subsequent feasibility testing in clinical studies (Phase II). In addition, the
research should include an integrated system(s) or components that can be
easily integrated into existing systems. Also, collaborative investigations
combining expertise in clinical trials and regulatory requirements using POC
devices in the areas of heart, lung, blood and sleep research will be
encouraged and these investigators should also begin considering applying for
this application.

The FOA is expected to be published in July, 2013 with an
expected application due date in October, 2013. This Notice is being provided
to allow potential applicants sufficient time to develop meaningful
collaborations and responsive projects.

This Notice specifically encourages investigators with
expertise and insights in the area of POC tools and technology that could
enhance clinical trials in the area of heart, lung, blood, and sleep research
to begin to consider applying for this new FOA.

This FOA will utilize the STTR R41/R42 activity codes. It is
expected that commercial POC products will be developed for use in the clinical
research setting at the POC. Preliminary details of the planned FOA are
provided below.

Research Initiative Details

The FOA will support multidisciplinary teams/networks (i.e.,
from technical to clinical expertise) not only in the development of advanced
technologies (e.g., bio-chips and platforms) but also in implementing existing
POC products for use in heart, lung, blood, and sleep clinical research.

Applicants should describe technical approaches and POC
methodologies, specify how they will achieve the proposed clinical objectives,
and include details on quality control and assurance, including standards for
handling samples being tested by a device. Once the POC tool/technology/test
has been developed and validated, investigators
will be expected to test the
feasibility of their product in heart, lung, blood, and sleep clinical
studies.

Applicants will be advised to consider carefully the context
in which their tools or technologies will be used to enhance clinical trials in
the area of heart, lung, blood, or sleep research and the interoperability with
existing health information technology systems. It is important to show early
involvement of the FDA in regards to the design of a trial especially for a
comparative trial.

The technologies developed with funding through the FOA are
expected to be integrated systems or, if they are novel components, be easily
integrated into existing systems. Proposed tools or technologies should
interoperate and communicate with existing health information technology
systems as appropriate. Some other technical features that are expected are
the following: reliability, robustness, safety, simplicity, reliance on the
appropriate baseline information, inclusion of software to support
decision-making, and consideration of power consumption. Proposed tools and
technologies should incorporate existing standards and consider regulatory
requirements where appropriate. In addition, global health concerns, improved
access to underserved areas, and cost-effectiveness should be highlighted.